Status:
COMPLETED
Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Breast Cancer
Eligibility:
FEMALE
19-75 years
Phase:
PHASE3
Brief Summary
The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC...
Detailed Description
This trial will compare the efficacy of docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as first line treatment in women with MBC
Eligibility Criteria
Inclusion
- Histologically- or cytologically- confirmed metastatic breast adenocarcinoma.
- No previous chemotherapy treatment for metastatic disease.
- No previous anthracycline treatment except as adjuvant therapy at least one year before.
- Age 19-75 years old
- Presence of measurable disease
- Performance status 0-2 (WHO)
- Adequate cardiac function (LVEF \>50%) without a recent (within 6 months) history of myocardial infraction and/or unstable or uncontrolled angina.
- Adequate bone marrow(absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3), liver (bilirubin \<1.5 times upper limit of normal and SGOT/SGPT \<2 times upper limit of normal) and renal function (creatinine \<2mg/dl).
- No previous radiotherapy to more than 25% of marrow-containing bones.
- Written informed consent
Exclusion
- Active brain metastases.
- Psychiatric illness or social situation that would preclude study compliance
- Other concurrent uncontrolled illness.
- Other invasive malignancy within the past 5 years except of nonmelanoma skin cancer.
- Positive pregnancy for premenopausal women.
- Concurrent antineoplastic treatment e.g. hormonal therapy
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT00429871
Start Date
May 1 2002
End Date
November 1 2007
Last Update
May 29 2009
Active Locations (10)
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1
University Hospital of Heraklion
Heraklion, Crete, Greece, 71110
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
4
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece